NCT06773195 · Memorial Sloan Kettering Cancer Center
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
What this study is about
The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.
View original scientific description
The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.
Interventions
DRUG
Ulixertinib
There are 3 planned dose levels of ulixertinib(450 mg BID, 300 mg BID, or 150 mg BID)
DRUG
Ruxolitinib
Ruxolitinib for 28 day cycles.
Primary outcome measures
Dose Limiting Toxicity evaluable participants
Time frame: up to 28 days
If none of the initial 3 patients in a cohort experience a dose limiting toxicity (DLT), then the next dose level will be studied in another cohort of 3 patients. If 1 of the initial 3 patients at a given dose level experience a DLT, up to 3 additional patients will be treated at that same dose level. Escalation will continue if not more than 1 of the 6 patients experience a DLT.
Response to therapy
Time frame: at week 25
as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT working criteria)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with a diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016 criteria.
- Age ≥18 years.
- Receiving ruxolitinib monotherapy for at least 3 months with stable dose (10 mg BID to 20mg BID) for at least 4 weeks before first dose of study drug. Note: stable ruxolitinib dosing should be achieved according to strict adherence to dose modification/reduction guidelines detailed in the ruxolitinib package insert, for patients with renal impairment, and/or hepatic impairment.
- Must have DIPSS+ intermediate 2 or greater risk disease, or MIPSS70+ intermediate or greater risk disease
- Persistent disease despite ruxolitinib monotherapy, as demonstrated by: o Grade 2 or 3 reticulin/collagen fibrosis on bone marrow AND
- Splenomegaly (palpable at least 5cm below subcostal margin/or spleen volume \> 450cm\^3) OR
- Active symptoms (MPN-SAF TSS score \>10 with at least one MPNSAF TSS score
Where
- Boston, Massachusetts
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
- Cleveland, Ohio
Collaborators
BioMed Valley Discoveries, Inc, Incyte Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations